Role OverviewLead the Global Central Laboratories QA organization, overseeing quality assurance for a kitting facility, clinical laboratory, and biorepository. This role requires strong leadership, regulatory compliance expertise, and the ability to drive continuous improvement.
What You Will Do
Develop and implement quality strategies, policies, and systems to maintain accuracy, reliability, and regulatory adherence in laboratory operations. Provide strategic leadership in quality management systems, ensure compliance with regulations, and lead internal and external audits.
Why It Might Be a Fit
This role is ideal for senior leaders with CLIA/CAP/ISO-15189 experience, looking for a challenging opportunity to right-size the existing GCL QA organization and enable expansion into new markets.
Requirements
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Medical Technology, or a related field
- 10+ years of experience in laboratory quality assurance, with at least 5 years in a senior leadership role
- Extensive experience in regulatory compliance (CLIA, CAP, FDA, ISO 15189, New York State (NYS), etc.)
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